| EXALIS, SOFTWARE VERSION 1.15 (K083158) | Gambro, Inc. | 2009-06-05 |
| RES-Q INFANT WEDGE AND SLING (K090284) | Cr Enterprises, LLC | 2009-06-05 |
| PROVOX VEGA, MODEL 8130-8135 (K090455) | Atos Medical AB | 2009-06-05 |
| VITREA ENDOVASCULAR STENT PLANNING SOFTWARE (K091498) | Vital Images, Inc. | 2009-06-05 |
| KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100 (K090273) | Kai Sensors, Inc. | 2009-06-05 |
| FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-5909 (K090772) | Andon Health Co, Ltd. | 2009-06-04 |
| R2 DIGITALNOW HD(DIGITALNOW HD) (K091368) | Hologic, Inc. | 2009-06-04 |
| EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS (K090629) | Tyson Bioresearch, Inc. | 2009-06-04 |
| FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5905 (K090770) | Andon Health Co, Ltd. | 2009-06-04 |
| OPTION VENA CAVA FILTER (K081410) | Rex Medical | 2009-06-04 |
| FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL, KD-5962 (K090771) | Andon Health Co, Ltd. | 2009-06-04 |
| SPEEDCEM (K091019) | Ivoclar Vivadent, Inc. | 2009-06-04 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961 (K090769) | Andon Health Co, Ltd. | 2009-06-04 |
| COLUMBUS REVISION KNEE SYSTEM (K083772) | Aesculap Implant System, Inc. | 2009-06-04 |
| FLOW CONTROLLER (K090938) | Odyssey Medical, Inc. | 2009-06-04 |
| MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200) (K091323) | Intermedic Arfran, SA | 2009-06-04 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD 5901, KD-7909, (K090768) | Andon Health Co, Ltd. | 2009-06-04 |
| MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S (K090114) | Oscor, Inc. | 2009-06-04 |
| THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS (K091253) | K2m, Inc. | 2009-06-04 |
| REVOLUTION FULL CORE BIOPSY (K090611) | Inrad | 2009-06-04 |
| SENSITITRE YEASTONE SUSCEPTIBILITY PLATES (K090968) | Trek Diagnostic Systems, Inc. | 2009-06-04 |
| C-QUR V -PATCH MESH (K090909) | Atrium Medical Corp. | 2009-06-04 |
| SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES (K090675) | Smith & Nephew, Inc. | 2009-06-04 |
| INTERTAN CHS LIMITED COLLAPSE SET SCREW (K090656) | Smith & Nephew, Inc. | 2009-06-03 |
| LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL (K083336) | Smiths Medical Asd, Inc. | 2009-06-03 |
| SE-601 SERIES ELECTROCARDIOGRAPH (K090367) | Edan Instruments, Inc. | 2009-06-03 |
| HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI (K090737) | Bio-Rad Laboratories, Inc. | 2009-06-03 |
| OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE (K090615) | Arthrocare Corp. | 2009-06-03 |
| PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM (K090934) | American Medical Systems, Inc. | 2009-06-02 |
| PENTA LEAD KITS, MODELS: 3227-3234 (K090907) | Advanced Neuromodulation Systems | 2009-06-02 |
| NEXLINK OCT SYSTEM, MODEL 7000 SERIES (K090060) | Abbott Spine, Inc. | 2009-06-02 |
| NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) (K090630) | Nobel Biocare AB | 2009-06-02 |
| X-RAY, TOMOGRAPHY, COMPUTED, DENTAL (K083917) | Suni Medical Imaging, Inc. | 2009-06-02 |
| I-MAX TOUCH (K083057) | Owandy | 2009-06-02 |
| EASY ON-PC SPIROMETER (K090034) | Ndd Medizitechnik AG | 2009-06-02 |
| MASTERGRAFT STRIP (K082166) | Medtronic Sofamor Danek | 2009-06-02 |
| HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS (K090209) | Instrumentation Laboratory CO | 2009-06-02 |
| BACKSTOP AND BACKSTOP INJECTOR (K090430) | Pluromed, Inc. | 2009-06-02 |
| MEGAPULSE LASER SYSTEM AND FIBERS (K090776) | Richard Wolf Medical Instruments Corp. | 2009-06-02 |
| OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER (K090206) | Oculus Innovative Sciences, Inc. | 2009-06-02 |
| BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY (K090824) | Becton, Dickinson & CO | 2009-06-02 |
| CODMAN HAKIM MICRO II VALVE (K091346) | Codman & Shurtleff, Inc. | 2009-06-02 |
| LOI SYSTEM (K090525) | Palomar Medical Products, Inc. | 2009-06-01 |
| EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM (K090415) | Eminent Spine | 2009-06-01 |
| CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G (K091322) | Ethicon Endo-Surgery, Inc. | 2009-06-01 |
| MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT (K091069) | Medacta International S.A. | 2009-06-01 |
| COMPEX REHAB (K090632) | Chattanooga Group | 2009-06-01 |
| PATHWAY AVID (K090566) | Custom Spine, Inc. | 2009-06-01 |
| POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE). (K090412) | Gx Corporation Sdn Bhd | 2009-06-01 |
| REVLITE Q-SWITCHED ND:YAG LASER SYSTEM (K083899) | Hoya Conbio, Inc. | 2009-06-01 |
| POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN (K091151) | Gx Corporation Sdn Bhd | 2009-06-01 |
| ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 (K090900) | Siemens Healthcare Diagnostics | 2009-06-01 |
| KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION (K083598) | KARL STORZ Endoscopy-America, Inc. | 2009-05-29 |
| CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C (K090052) | Johari Digital Healthcare , Ltd. | 2009-05-29 |
| RESPIRONICS PERFORMAX TOTAL FACE MASK (K091271) | Respironics Inc., Sleep & Home Respiratory Group | 2009-05-29 |
| MODEL 350G GAS CONSERVER (K090421) | Inspired Technologies, Inc. | 2009-05-29 |
| ISOFLOW INFUSION CATHETER (K081147) | Vascular Designs, Inc. | 2009-05-29 |
| HEMORPEX SYSTEM (K090432) | Angiologica B. M. Srl | 2009-05-29 |
| TANTHERA-T35 (K090831) | Tanthera, Inc. | 2009-05-29 |
| NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGS (K082957) | Siam Sempermed Corp., Ltd. | 2009-05-29 |
| DIGITAL RADIOGRAPHY MODEL CXDI-55G (K091435) | Canon, Inc. | 2009-05-29 |
| EXTT-101 (K082436) | Apimeds, Inc. | 2009-05-29 |
| SRI LEVEL II SURGICAL GOWN (K090383) | Sri Surgical | 2009-05-29 |
| QMS LIDOCAINE (K090282) | Thermo Fisher Scientific, Inc. | 2009-05-29 |
| DIGITAL RADIOGRAPHY, MODEL CXDI-55C (K091436) | Canon, Inc. | 2009-05-29 |
| THE CROSSER 14 OTW CATHETER, MODEL CRU014 (K091254) | Flowcardia, Inc. | 2009-05-29 |
| PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH (K091329) | Terumo Medical Corp. | 2009-05-29 |
| DEXIS SENSOR (K090458) | Dexis, LLC | 2009-05-28 |
| DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT (K090528) | C.R. Bard, Inc. | 2009-05-28 |
| ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01 (K083117) | Phadia US, Inc. | 2009-05-28 |
| PERCUCATH URINARY CATHETER (K090262) | Percuvision, LLC | 2009-05-28 |
| BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM (K090957) | I2s Micro Implantable Systems, LLC | 2009-05-28 |
| DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES (K090979) | Encision, Inc. | 2009-05-28 |
| ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS (K090071) | Rostam , Ltd. | 2009-05-28 |
| IMMUNOCARD STAT CAMPY, MODEL 751530 (K090700) | Meridian Bioscience, Inc. | 2009-05-28 |
| INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 (K081769) | Siemens Healthcare Diagnostics | 2009-05-28 |
| CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS (K090602) | Cardiodynamics International Corp. | 2009-05-28 |
| ECSCOPE 100 (K091358) | Dyansys, Inc. | 2009-05-28 |
| PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 (K091195) | Philips Medical Systems (Cleveland), Inc. | 2009-05-27 |
| POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210 (K090588) | Beckman Coulter, Inc. | 2009-05-27 |
| RADCALC SOFTWARE, VERSION 6.0 (K090531) | Lifeline Software, Inc. | 2009-05-27 |
| XYLOS POROUS SURGICAL MESH (K090880) | Xylos Corporation | 2009-05-27 |
| FLEXIPLAN 3D AND 3D+ (K091145) | Isodose Control B.V. | 2009-05-27 |
| SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0 (K090420) | Smith & Nephew, Inc. | 2009-05-27 |
| JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02) (K090856) | Thyssenkrupp Ceteco Srl | 2009-05-27 |
| NEUROMETRIX BIOAMPLIFIER (K083322) | Neurometrix, Inc. | 2009-05-27 |
| RIC CONFORMAL SOURCE, MODEL 100 (K090321) | Ri Consultants, LLC | 2009-05-27 |
| EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER (K082858) | Alcavis International, Inc. | 2009-05-27 |
| FLUID FILLED TEETHER (K082824) | Kids II | 2009-05-27 |
| WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H (K091212) | Wu'S Tech Co., Ltd. | 2009-05-27 |
| ORTHODONTIC CERAMIC BRACKET (K090567) | Star Dentech Korea., Corp | 2009-05-27 |
| ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089 (K090943) | American Biological Technologies, Inc. | 2009-05-27 |
| BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY (K090827) | Becton, Dickinson & CO | 2009-05-27 |
| PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501 (K091097) | Promedical Products Co., Ltd. | 2009-05-27 |
| SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE (K083118) | Spinal USA | 2009-05-27 |
| ACTIVAPATCH (K091326) | Activatek, Inc. | 2009-05-27 |
| 506CN PATIENT MONITOR (K091050) | Criticare Systems, Inc. | 2009-05-27 |
| REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1 (K082419) | Intra-Lock International, Inc. | 2009-05-27 |
| GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND (K091374) | Ge Medical Systems China Co., Ltd. | 2009-05-26 |
| FUSION MEDICAL CANNULATED SCREW SYSTEM (K081122) | John Riccio | 2009-05-26 |